ALFINOR Tablet Ref.[28109] Active ingredients: Betahistine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivertigo preparations, Other Nervous System Drugs
ATC code: N07CA01

Betahistine didydrochloride is a histamine analogue which can be administered orally. Studies in animals showed that the drug cause vasodilation of capillaries/arterioles of the spiral ligament and stria vascularis after topical or iv administration.

In patients with Meniere’s syndrome the drug appears to exert its activity by reducing endolymphatic pressure.

5.2. Pharmacokinetic properties

After oral administration, betahistine is quickly and completely absorbed. Peak plasma levels occur one hour after administration. It is metabolised to liver to at least two inactive metabolites. The majority of the drug is excreted in urine as metabolites.

The half-life of betahistine is 3.5 hours.

5.3. Preclinical safety data

When betahistine was administered orally to rats and dogs at doses up to 250 mg/kg/day no adverse reactions were observed.

Parenteral administration (IV) of betahistine to dogs and monkeys at dose of 120 mg/kg/day produced side effects such as vomiting and neurological disorders (like those produced from histamine).

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